cleanroom operations

 

  Develop Standard Operating Procedures Using IEST Recommended Practices

 

Learn how to write an effective standard operating procedure incorporating the fundamentals of IEST recommended practices.  Effective SOP's will create a robust contamination control program in your cleanroom operations.  Be prepared to write your compnay's standard operating procedure for the selection of cleanroom garments and gowning in your cleanrooms, a standard operating procedure for behavior in your cleanroom and a standard operating procedure for testing and monitoring your cleanroom.

Course outline     Who should attend?     Course materials    

Instructor     Next date and location

 



Course outline

  1. Best practices for SOP development
    1. Create a SOP that directs:
      1. How to write a SOP
      2. Review a SOP
      3. Approve a SOP
      4. Distribute a SOP
      5. Review and revise all SOP’s
  2. Harmonization with industry standards
    1. ISO 14644-5 Cleanrooms and Associated Controlled Environments – Operations
    2. FDA c GMP’s
  3. Development of Process Map of Cleanroom Operations
    1. Linear product flow
    2. Linear personnel flow
  4. SOP Content
    1. Header
      1. Company name
      2. Supersedes date
      3. Effective date
      4. Procedure number
      5. Procedure name
    2. Approval signatures and date
    3. Purpose
    4. Scope
    5. Definitions
    6. Applicable reference documents
    7. Procedure
      1. Specifications
      2. Materials and equipment
      3. Methods
      4. Diagrams, flow charts, Visuals
      5. Records and forms NOTE:  Must link form to SOP.
    8. Corrective Action
    9. Preventive Action
    10. Change History
    11. Confidentiality and document control
  5. Compliance
    1. Changing SOP’s
      1. Describe areas of SOP to be changed
      2. Rationale for the change – what and why
      3. Validation data
      4. Temporary or permanent change
      5. Approval signatures and dates
    2. Training to SOP’s
      1. Review written SOP
      2. Written test to check for comprehension
      3. Performance of SOP
      4. Periodic review and assessment of efficacy and validity of SOP
    3. Continuous training and positive reinforcement of procedures and policies
    4. Continuous audits for compliance
    5. Continuous improvement through six sigma initiatives, etc.
    6. Continuous documentation of all activities.
  6. Workshop
  7. Create individual SOP’s on company template to:
    1. IEST-RP-CC003 – Cleanroom Garments and Gowning
    2. IEST-RP-CC027 – Cleanroom procedures, practices and policies
    3. IEST-RP-CC006 – Testing cleanrooms and environmental monitoring

 

Who should attend?

Information coming soon.

 

Course materials

  • Copy of PowerPoint presentation in course binder
  • Certificate of attendance for completion of CEUs

Continuing Education Units: .6 CEUs

Instructor

 Jan Eudy

 


Next dates and locations

August 26 and 27, 2020
12 - 3:30 p.m. Central Time
Virtual
Early-bird deadline ends July 31! Use coupon code 8EB820SOP to save 10% off.
Registration closes August 21


 
Registration information

Register three attendees from your company for the same training course and receive a complimentary fourth registration for another person in your company to attend that course. Contact IEST at 847-981-0100 to arrange this option. (Complimentary registration applies to registration of equal or lesser value. Not valid with any other offers or promotions.)
 
Registration Fees Regular

Member
Non-member

$475
$575

 

 

REGISTRATION POLICY

IEST reserves the right to cancel course(s), in which case registrants will receive a refund of the fee. IEST is not responsible for any refund or remuneration for hotel, transportation, additional registration fees, tours, or other expenses related to attendance beyond the registration fee refund.

All orders must be paid in full at the time the order is processed. IEST does not invoice or accept purchase orders as payment. IEST reserves the right to charge a 5% administrative fee on additional transactions arising from customer order errors and a $40 fee for non-sufficient fund checks or credit card charge claims in error.

Transfers: Registrations are transferable to another person for the same event. A $35 transfer fee applies. Transfer of a member registration to a nonmember registration will be charged the difference in fees. 

Cancellations: Cancellation requests received 60 days or more prior to the start of the event will receive a full refund LESS a $75 administration fee. Cancellation requests received 30-59 days prior to the start of the event will receive a 50% refund. No refunds will be issued for cancellation requests received less than 30 days prior to the start of the event. Virtual training courses: No refunds for any reason will be issued after course instructions and materials have been sent to attendees.

  • IEST reserves the right to cancel courses, in which case registrants will receive a full refund of the tuition fee.
  • Program and instructor(s) are subject to change.
  • Payment must accompany registration; there is no invoicing. IEST does not accept purchase orders as a method of payment.
  • All member dues must be current at the time of registration to qualify for the member rates.
  • All education training courses earn Continuing Education Units.

Download print registration form

Warning: Commercial, for-profit training companies have sprung up that are using the same course titles and promotional text as in IEST courses. Please be aware that IEST does not support, approve, provide any recognition of, or expertise to such courses. IEST does not assume any liability for the material presented in such courses. Registrations for IEST courses are only available through the IEST website.

Corporate Sponsors

Thank you to our the support from our Corporate Sponsors

Presidential Level